Main Responsibilities
Provide regulatory guidance and support for Drug Master File (DMF) submissions and updates in Japan.
Communicate effectively with Marketing Authorization Holders (MAHs) and the Pharmaceuticals and Medical Devices Agency (PMDA).
Translate DMF-related documents between English and Japanese.
Manage PMDA submissions and oversee the accreditation process for foreign manufacturers.
Support pharmacovigilance inspections (GVP) as needed.
Deliver regulatory intelligence and updates on Japanese pharmaceutical regulations to clients.
Occasionally participate in global projects, including those based in the EU and US.
Assist with business development initiatives.
Requirements
Minimum of 5 years’ experience in regulatory affairs, specifically related to API or pharmaceutical product registration with the PMDA.
In-depth knowledge of Japanese pharmaceutical regulatory frameworks.
Native-level Japanese and business-level English proficiency (both written and verbal).